FDA Registration
Active
🇺🇸 United States
Orthosis, spondylolisthesis spinal fixation KWQ - Appliance, fixation, spinal intervertebral body
Reg #: 3009923627
·
FEI: 3009923627
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Arch Medical Solutions - Elkhart
- Registration Number
- 3009923627
- FEI Number
- 3009923627
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2921 Lavanture Pl
- City
- Elkhart
- State
- IN
- ZIP
- 46514
- Country
- US
Regulatory Submissions
- 510(k) Number
- K121922
Owner / Operator
- Firm Name
- Arch Medical Solutions - Elkhart
- Operator Number
- 10042003
- Address
- 2921 LaVanture Place
- City
- Elkhart
- State
- IN
- Postal Code
- 46514
- Country
- US
- Correspondent
- Troy A Kline
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-11-27 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-11-27 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-11-27 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-11-27 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-11-27 |
Proprietary Names
Orthosis, spondylolisthesis spinal fixation KWQ - Appliance, fixation, spinal intervertebral body
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)